Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation

Pregnancy Clinical Trial

Official title:

Effect of Maternal Choline Intake on Maternal/Fetal Biomarkers of Choline Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127022
• Other study ID #: OSP No: 59370, 57100, 58222
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: September 17, 2013
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of varied maternal choline intake on maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.

Description:

Choline is a micronutrient used for the structural integrity of cell membranes, lipid transport/metabolism, methylation reactions and cholinergic neurotransmission. Prenatal and early postnatal choline exposure plays a critical role in brain development and cognition based on animal data. Although it is recognized that choline use is particularly high during pregnancy and lactation, the level of choline intake needed to optimize maternal and fetal health outcomes is unknown. The primary objective of this study was to investigate the metabolic and genomic effects of two doses of choline intake, 450 mg/d (the adequate intake level for pregnant women) and 900 mg/d in pregnant, lactating, and nonpregnant control women. A secondary objective was to examine the effect of extra maternal choline intake on the child's cognitive performance (i.e, learning, memory and attention). To accomplish these objectives, pregnant women (wk 27 gestation), nonpregnant control women, and lactating women consumed controlled choline intakes of 480 or 930 mg/d for 10 to 12 weeks. The basal diet provided 380 mg/d; supplemental choline chloride, 100 or 550 mg/d, was used to achieve the target intake levels. During the last half of the study, a small portion (~ 20%) of the total choline intake was derived from deuterium labeled choline, a stable isotope. Blood, urine and/or breast milk were collected at baseline and at select timepoints throughout the study duration. For pregnant women, a maternal blood sample was obtained at the time of delivery along with a cord blood sample and the placental tissue. Genomic and metabolomic profiling were performed on the collected biological samples along with specific measurements of choline status. Non-invasive tests assessing cognitive function were performed on the children of the pregnant and lactating study participants. This controlled feeding study has also been extended to investigate dose-response relationships for other micronutrients including folate, vitamin B12, vitamin D, and biotin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Pregnant (wk 27 gestation) or lactating (postnatal day 30) or nonpregnant

• Healthy

• Non-smoker

Exclusion Criteria:

• Liver or kidney problems

• Alcohol or illegal drug misuse/abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lactation
• Pregnancy

Intervention

Dietary Supplement:
• choline chloride
Women will consume a diet providing 380 mg/d total choline plus 100 mg/d supplemental choline [from choline chloride] for a total choline intake of 480 mg/d. The choline chloride will be administered in cran-grape juice.
• Choline Chloride
Women will consume a diet providing 380 mg/d total choline plus 550 mg/d supplemental choline [from choline chloride] for a total choline intake of 930 mg/d. The choline chloride will be administered in cran-grape juice.

Locations

Country	Name	City	State
United States	Human Metabolic Research Unit, Cornell University	Ithaca	New York

Sponsors (4)

Lead Sponsor	Collaborator
Cornell University	American Egg Board, National Cattlemen's Beef Association, USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

Jiang X, Bar HY, Yan J, Jones S, Brannon PM, West AA, Perry CA, Ganti A, Pressman E, Devapatla S, Vermeylen F, Wells MT, Caudill MA. A higher maternal choline intake among third-trimester pregnant women lowers placental and circulating concentrations of t — View Citation

Jiang X, Bar HY, Yan J, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen FM, Wells MT, Caudill MA. Pregnancy induces transcriptional activation of the peripheral innate immune system and increases oxidative DNA damage among healthy thir — View Citation

Jiang X, Yan J, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Caudill MA. Maternal choline intake alters the epigenetic state of fetal cortisol-regulating genes in humans. FASEB J. 2012 Aug;26(8):3563-74. doi: 10.1096/fj.12-207894 — View Citation

West AA, Yan J, Jiang X, Perry CA, Innis SM, Caudill MA. Choline intake influences phosphatidylcholine DHA enrichment in nonpregnant women but not in pregnant women in the third trimester. Am J Clin Nutr. 2013 Apr;97(4):718-27. doi: 10.3945/ajcn.112.05021 — View Citation

West AA, Yan J, Perry CA, Jiang X, Malysheva OV, Caudill MA. Folate-status response to a controlled folate intake in nonpregnant, pregnant, and lactating women. Am J Clin Nutr. 2012 Oct;96(4):789-800. Epub 2012 Aug 29. — View Citation

Yan J, Jiang X, West AA, Perry CA, Malysheva OV, Devapatla S, Pressman E, Vermeylen F, Stabler SP, Allen RH, Caudill MA. Maternal choline intake modulates maternal and fetal biomarkers of choline metabolism in humans. Am J Clin Nutr. 2012 May;95(5):1060-7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal biomarkers of choline status		10-12 Weeks	No
Secondary	Genomic expression as function of maternal choline intake		10-12 Weeks	No
Secondary	Cognitive performance in children of study participants		12 months	No
Secondary	Metabolomic profiling as a function of maternal choline intake		10-12 Weeks	No
Secondary	Biomarkers for additional micronutrients		10-12 Weeks	No